MAUDE Adverse Event Report: COVIDIEN (IRVINE) ATK TURBOHAWK CALCIUM; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number THS-LX-C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the turbohawk device was visually inspected - biological debris were noted within the laser drilled coil.No damage to the turbohawk unit was noted.The cutter assembly was retracted back into the cutter window.Unknown clear debris was noted behind the cutter.Functional testing was performed - the thumb-switch was attempted to be pushed forward but encountered resistance.A cutter driver from the lab was connected to the turbohawk and activated.The cutter was able to be advanced approximately 2.8cm from the cutter window.The cutter was retracted and observed a strip of clear material wound up around the cutter blank.The strip of material was removed using a tweezers and soaked in water.After approximately 48 hours of soaking the debris did not dissolve.The material was clear and plastic-like.It should be noted the outer layer (hydrophilic coating) on the outer distal rim of the cutter window showed peeling.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a turbohawk directional atherectomy device to treat a lesion in the sfa with 70% stenosis.The lesion exhibited severe calcification and tortuosity.It was reported that during the procedure, physician was unable to open the cutter head.Another device was used to complete the procedure.No patient injury reported.

• Brand Name: ATK TURBOHAWK CALCIUM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine; california CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine; california CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6861174
• MDR Text Key: 86092884
• Report Number: 2183870-2017-00389
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A158413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR